510(k) K071074
K071074 is an FDA 510(k) premarket notification submitted by Showa Ika Kohgyo Co., Ltd. for the device "MYKRES SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 2, 2008. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Showa Ika Kohgyo Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 2, 2008
- Date Received
- Apr 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Orthosis, Spinal Pedicle Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)